BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DA VINCI S SURGICAL SYSTEM

    MDR report key: 1646669 · Received March 26, 2010

    Report

    Report Number
    2955842-2010-00121
    Event Type
    Injury
    Date Received
    March 26, 2010
    Date of Event
    September 16, 2009
    Report Date
    February 7, 2010
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Product Code
    NAY
    PMA / PMN Number
    K081207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON MARCH 18, 2010, THE SURGEON REPORTED THAT THE PATIENT EXPERIENCED MOTOR WEAKNESS IN HER RIGHT HAND THAT PREVENTED HER FROM OPENING HER HAND. THE SURGEON ALSO REPORTED THAT THERE WAS NO MALFUNCTION OF THE DA VINCI S SURGICAL SYSTEM DURING THE PROCEDURE, AND THAT HE BELIEVES THE INJURY TO THE PATIENT'S RADIAL NERVE WAS DUE TO THE PATIENT'S ARM POSITIONING. IN ADDITION, THE SURGEON REPORTED THAT AFTER 3 MONTHS OF OUT-PATIENT PHYSICAL THERAPY THE PATIENT HAS FULLY RECOVERED AND SUSTAINED NO PERMANENT DAMAGE. AS OF MARCH 18, 2010, THERE HAVE BEEN NO REPORTED RECURRENCES OF THE ISSUE AT THIS HOSPITAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST A DA VINCI S THYROIDECTOMY PROCEDURE, THE PATIENT EXPERIENCED NUMBNESS, DUE TO RADIAL NERVE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DA VINCI S SURGICAL SYSTEM ENDOSCOPIC INSTRUMENT CONTROL SYSTEM NAY INTUITIVE SURGICAL, INC. IS2000 A51.P8

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other DVS INSTRUMENTS| ACCESSORIES